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Merck

TZHALA205

Steritest® NEO Device

For liquids in ampoules or collapsible bags., Blue base canister with a single-needle adapter., pkg of 10 blisters in 2 bags of 5 blisters per box, double packed

동의어(들):

Blue Base Steritest® NEO device for sterility testing

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제품정보 (DICE 배송 시 비용 별도)

UNSPSC Code:
23151818
NACRES:
NB.24
eCl@ss:
32014001
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Quality Segment

material

Nylon 66 adapter (for needle), PVC tubing (double lumen), mixed cellulose esters (MCE) membrane, plain filter, stainless steel (for needle), styrene-acrylonitrile (SAN) (for canister)

agency

EP (2.6.1), JP (4.06), USP 71

sterility

sterile; γ-irradiated

feature

Blue base canister with a single-needle adapter.

manufacturer/tradename

Steritest®

packaging

pkg of 10 blisters in 2 bags of 5 blisters per box, double packed

parameter

120 mL sample volume (graduation marks at 25, 50, 75 and 100 mL), 3.1 bar max. inlet pressure (45 psi) at 25 °C, 45 °C max. temp.

tubing L

850 mm

color

blue Canister Base

matrix

MF-Millipore

pore size

0.45 μm pore size

input

liquid
sample type pharmaceutical(s)

application(s)

pharmaceutical
sterility testing

compatibility

For liquids in ampoules or collapsible bags.

shipped in

ambient

General description

Device Configuration: 2 canisters

Steritest® NEO is a membrane filtration device for sterility testing of filterable pharmaceutical products. The device simplifies every aspect of testing, from handling to traceability. The closed system ensures that pharmaceutical products are never exposed to the environment, minimizes false positives, and offers the highest levels of quality and reliability. This test system offers an optimized and fully regulatory compliant testing process when used with the Steritest® Symbio pump, specific accessories and high-quality culture media and rinsing fluids. The device is gamma sterilized and double packed for the quick transfer into sterility testing environments, simplifying decontamination procedures and saving time. A single needle adapter enables an easy access to ampoules or collapsible bags. A separate vent needle is included for the transfer of the test product, culture media or rinsing buffer. The blue based canisters indicate mixed cellulose ester (MCE) membrane, which provides an optimal filtration flow rate for standard products. The new Velax® cutting clamp allows a safe and clean disconnection of the tubing and is readily mounted on all Steritest® NEO devices.

Application

The Steritest® NEO Device for liquids in ampoules or collapsible bags is used for sterility testing of large volume parenterals and synthetic drugs without antimicrobial activity.

Legal Information

MF-Millipore is a trademark of Merck KGaA, Darmstadt, Germany
STERITEST is a registered trademark of Merck KGaA, Darmstadt, Germany
VELAX is a registered trademark of Merck KGaA, Darmstadt, Germany


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저장 등급

11 - Combustible Solids



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